A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.

A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in Patients With Type 2 Diabetes Mellitus

As current study is conducted to provide additional information regarding safety and efficacy Bydureon, exenatide once weekly for injectable suspension, in the Korean population open label, non-comparative, multi-centre design is used.

Inclusion Criteria:

• Male or female, 19-75 years of age

• diagnosed with type 2 diabetes mellitus

• Patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies;

  • Metformin
  • Sulphonylurea
  • Thiazolidinedione
  • Metformin and sulphonylurea
  • Metformin and thiazolidinedione

Exclusion Criteria:

• Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:

  1. Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
  2. Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
  3. DPP-4 inhibitors within 30 days of screening;
  4. Regular use (> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;
  5. Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of screening;
  6. GLP-1 receptor agonist except exenatide within 3 months of screening;

• diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;

• type 2 diabetes by beta-cell dysfunction requiring insulin treatment

• Has ever used exenatide

• Pregnant or breast feeding patients

• Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal

• End-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min)